This role of the Process Validation Specialist is to coordinate the execution of Performance Qualification and Process Performance Qualification activities in support of all manufacturing activities and in accordance with Regulatory requirements.
Skills and Experiences required for this role:
- Have knowledge of Validation Life Cycle documentation deliverables and how to implement a Risk based approach is central to the skills base of this position.
- The role will include the writing, review and execution of Process Validation plans, protocols and reports and the coordination of support activities to deliver on time a high standard of documentation.
- The candidate will have a degree in Science or Engineering or equivalent and recognised academic achievement and have Project Management experience.
- Ability to execute and witness Process Validation studies in line with the production schedule
Key responsibilities include:
- To coordinate the execution of the Validation Master Plan with respect to Process Validation activities.
- Assess Change control documentation to determine change impact with respect to the validation requirements and report appropriately.
- To support operational areas in the implementation of change.
- Supports Process Validation activities.
- Define Process Validation Strategies in conjunction with the Process Validation Lead
- Author and review Process Validation plans, protocols and reports ensuring compliance to policies and procedures.
- Schedule and support Process Validation executions.
- High level of technical and scientific writing required.
- Understand and Applies statistical tools for development of protocols and data analysis for Process Validation. Participate in Continued Process Verification Activities (CPV) including the generation of CPV plans and CPV reporting.
- Present Process Validation documents at regulatory audits.
- Performs process investigations with relevant departments as required.
- Performs product and process impact assessments.
- Participates in or Lead process and quality risk assessments.
- Presents findings at group and at interdepartmental meetings.
- Communicate information on current process data which may impact Process Validation.
- Maintain and review the Product Control Strategy for all products. Understand the functional relationships that link CMA/CPP to CQA.
- To ensure the timely completion of Deviations and the closure of CAPAs
This is a permanent full time role based in Porton Science Park, the role comes with free parking and multiple benefits to working on site.
To apply for this role, please contact Liam@requireconsultancy.com